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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-IOR-16009721
Date of registration: 2016-11-03
Prospective Registration: No
Primary sponsor: Institute of Organ Transplantation, Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology
Public title: A clinical study of hydrogen-rich solution in kidney transplantation from marginal allograft
Scientific title: A clinical study of hydrogen-rich solution using for marginal renal allograft in kidney transplantation -- a single center, randomized, controlled, double-blinded study
Date of first enrolment: 2016-11-01
Target sample size: HRS Group:50;Controlled group:50;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=13483
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  Other
Countries of recruitment
China
Contacts
Name: Gang Chen   
Address:  1095 Jiefang Avenue, Wuhan, Hubei, China
Telephone: +86 13006187015
Email: gchentj@vip.163.com
Affiliation:  Institute of Organ Transplantation, Tongji Hospital, Tongji Medical School, University of Huazhong Science and Technology
Name: Lan Zhu   
Address:  1095 Jiefang Avenue, Wuhan, Hubei, China
Telephone: +86 13971570206
Email: susanne.zhu@qq.com
Affiliation:  Institute of Organ Transplantation, Tongji Hospital, Tongji Medical School, University of Huazhong Science and Technology
Key inclusion & exclusion criteria
Inclusion criteria: 1. DCD donor aged 18-65 years male or female;
2. Last sereum creatinine of DCD donors before donation should be >150umol/L;
3. Patienst would recieve the first time renal translantation due to uremia;
4. Recipients aged 18-60 years male or female;
5. Patients willing to voluntee to participate, and to sign an informed consent form.

Exclusion criteria: 1. Pateints who do not meet the inclusion criteria;
2. Patients who are HLA presensitized before renal transplantation,including patients either with positive PRA or a history of pretransplantation;
3. Patients who have high risk of recurrence disease after renal transplantation (FSGS,IgA nephropathy);
4. Patients who would undergo multi-organ transplantation;
5. Patients who are pregnant orlactating.


Age minimum: 18
Age maximum: 60
Gender: Both
Health Condition(s) or Problem(s) studied
Delayed graft function in kidney transplantation
Intervention(s)
HRS Group:Hydrogen-rich solution;Controlled group:regular solution;
Primary Outcome(s)
rate of Delayed Graft Function(DGF);
Secondary Outcome(s)
serum creatinine;eGFR;HMGB-1;
Secondary ID(s)
Source(s) of Monetary Support
Funds from Miz company in Japan and self-raised
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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